component manufacturer / pharmaceutical and microbiological laboratories / specification developers / biological products / manufacturing activities / products / pharmaceutical production process / contract manufacturers / drug/ device / drug product / co-packaged combination product / pre-existing manufacturing approach / specification developer / to combination products / human drug products / combination product manufacturer / noncombination products / pharmaceutical process / overall manufacturing process / manufacturing practice requirements / manufacturing practices / investigational combination product / particular manufacturer / biologic product / biological product / particular product / co-packaged and cross-labeled combination products / manufacturing practice / finished combination product manufacturer / drug manufacturer / manufacturing process / to biological products / Appropriate manufacturing controls / pharmaceutical laboratory testing records / final product / cross-labeled combination product / co-packaged combination products / finished combination product / otherwise manufacturing / drug-device combination product / medical products / biologic/device / investigational devices / internal auditing / medical product / manufacturing steps / combination product / contract manufacturer / pharmaceutical laboratory control / singleentity combination product / manufacturing / offthe-shelf product / manufacturing operations / chemical means / device products / combination products / them to combination products / drug products / non-combination medical products / pre-manufacturing design control requirements / manufacturing problems / biological product-drug combination product / cross-labeled combination products / cellular and tissue-based products / marketed products / /
MedicalCondition
sterility / /
Organization
Western Service Center / Combination Products AGENCY / DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / office of Combination Products / FDA / /
Person
Clark Desing / Silver Spring / John Barlow Weiner / /
Position
Manager / Operations Support Group / A. General / Proposed Rule A. General / /
Product
CGMPs / /
ProvinceOrState
Maryland / Washington / /
Technology
design verification / operating system / operating systems / http / /
Federal Register / Vol. 78, No[removed]Tuesday, January 22, [removed]Rules and Regulations Issued in Seattle, Washington, on December 19, 2012. Clark Desing, Manager, Operations Support Group, Western Service Center.